Pulmonary Disease, Chronic ObstructiveBPCeauxNCT01296854
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
A study testing Spa therapy in people with Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesFrance
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient must have chronic obstructive pulmonary disease
- Obstructive ventilation problem: Tiffeneau index (expiratory volume in one second / slow vital capacity) < 70%
- Expiratory volume in one second < 80% of the theoretical value
- Reversibility < 12% after inhalation of bronchodilators
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- Smokers or ex smokers
- Available for study monitoring
- Has access to diagnostic, medical and therapeutic care according to the best, current criteria (see the recommendations of the French Language Pseumologist Society)
Who cannot join
- The patient is participating in another study
- The patient has participated in another study in the past 12 months
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
Show all 19Show fewer
- The patient is in military service (unavailable for monitoring)
- Patient is on parole or otherwise has their liberty restricted by administrative or judiciary decision
- The patient is pregnant, or does not have contraception
- The patient is breastfeeding
- Patient has neoplastic disease
- Patient has asthma
- Patient has another, evolving pulmonary disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
- Patient has a clinical history indicating asthma or another respiratory disease (in particular bronchiectasis, pneumoconiosis and other occupational diseases, history of pulmonary neoplasia, HIV, immunosuppressive therapy including corticosteroids in the long term
- Patient has respiratory insufficiency
- Hypereosinophilic patient (the number of polynuclear eosinophils is > 0.5 giga/l; confirmed on 2 hemograms)
- Recent psychiatric trouble (less than 1 year)
- Takes illegal drugs
- Patient does not have pneumological care according to the standards set by the French Language Pneumologist Society
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Private practice: Karim Berkani
Aix-les-Bains, 73100
Private practice: Jean Hérété
Amélie Les Bains Palalda, 66110
Private practice: Pierre Ethève
Briey, 54150
Private practice: Marc Bellier
Ceret, 66400
Private practice: Pierre Olivier
Perpignan, 66000
Private practice: Muriel Nouvelle
Saint-Amand-les-Eaux, 59230
About this study
The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Spa therapy
- Keywords
- spa therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapyOther
3 weeks of spa therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | The patients randomized into this arm of the study will not have spa therapy. |
| Spa Therapy | Experimental | The patients randomized into this arm of the study will have 3 weeks of spa therapy Receives: Other: Spa therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
Measured: 12 months after the beginning of treatment
Secondary outcomes (21)
change in the BODE score
Measured: 3 weeks
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Measured: 3 weeks
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Measured: 3 weeks
C reactive protein (mg/l)
blood work
Measured: 3 weeks
Eosiniphil count (thou/ml)
blood work
Measured: 3 weeks
Number of exacerbations
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
Measured: 3 weeks
change in the BODE score
Measured: 3 months
change in the BODE score
Measured: 6 months
change in the BODE score
Measured: 9 months
change in the BODE score
Measured: 12 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Measured: 3 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Measured: 6 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Measured: 9 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Measured: 12 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Measured: 3 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Measured: 6 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Measured: 9 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Measured: 12 months
Number of exacerbations
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
Measured: 3 months
Number of exacerbations
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
Measured: 6 months
Number of exacerbations
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: The feasability of inclusions has proven very low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Molinari, PhD, Study director, Centre Hospitalier Universitaire de NīmesJean Victor Hérété, MD, Principal investigator, Amélie les Bains
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296854
- Sponsor's protocol ID
- LOCAL/2010/NM-02
- Other IDs
- 2010-A00693-36
- Acronym
- BPCeaux
- Status last verified
- Mar 2015
- First submitted
- 15 Feb 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01296854
- Acronym / sponsor ID
- BPCeaux / LOCAL/2010/NM-02
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- spa therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The feasability of inclusions has proven very low.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –The patients randomized into this arm of the study will not have spa therapy. |
| Spa Therapy | Experimental | Other: Spa therapyThe patients randomized into this arm of the study will have 3 weeks of spa therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient must have chronic obstructive pulmonary disease
- Obstructive ventilation problem: Tiffeneau index (expiratory volume in one second / slow vital capacity) < 70%
- Expiratory volume in one second < 80% of the theoretical value
Key exclusion criteria (19 listed)
- The patient is participating in another study
- The patient has participated in another study in the past 12 months
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapy3 weeks of spa therapy | Other | Spa Therapy |
Primary outcome
Number of exacerbations
Time frame: 12 months after the beginning of treatment
Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in >=2 of the following minor symptoms for >= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay > 24h, and as "moderate" otherwise.
21 secondary outcomes
change in the BODE score
Time frame: 3 weeks
change in SF36 questionnaire scores
Time frame: 3 weeks
Cost (€)
Time frame: 3 weeks
C reactive protein (mg/l)
Time frame: 3 weeks
Eosiniphil count (thou/ml)
Time frame: 3 weeks
Number of exacerbations
Time frame: 3 weeks
change in the BODE score
Time frame: 3 months
change in the BODE score
Time frame: 6 months
change in the BODE score
Time frame: 9 months
change in the BODE score
Time frame: 12 months
change in SF36 questionnaire scores
Time frame: 3 months
change in SF36 questionnaire scores
Time frame: 6 months
change in SF36 questionnaire scores
Time frame: 9 months
change in SF36 questionnaire scores
Time frame: 12 months
Cost (€)
Time frame: 3 months
Cost (€)
Time frame: 6 months
Cost (€)
Time frame: 9 months
Cost (€)
Time frame: 12 months
Number of exacerbations
Time frame: 3 months
Number of exacerbations
Time frame: 6 months
Number of exacerbations
Time frame: 9 months
Results and safety
The study was stopped early (reason given: The feasability of inclusions has proven very low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Molinari, PhD study director
Centre Hospitalier Universitaire de Nīmes
Jean Victor Hérété, MD principal investigator
Amélie les Bains
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy in people with Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The feasability of inclusions has proven very low.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exacerbations (time frame: 12 months after the beginning of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.